Biosimilarity of Recombinant Human EPO Products from CHO Cell Lines: A Carbohydrate Structural View View Full Text


Ontology type: schema:Chapter     


Chapter Info

DATE

2010-06-02

AUTHORS

Nicolas Grammel , Frank Dittrich , Sebastian Kandzia , Eckart Grabenhorst , Harald S. Conradt

ABSTRACT

The detailed knowledge of the N- and O-linked oligosaccharides of recombinantly produced human glycoprotein therapeutics is a prerequisite for their use in patients. From the regulatory point of view (EMEA, FDA), the carbohydrates of therapeutic glycoproteins (e.g. EPO, IFN-ß, therapeutic antibodies) play a key role in efficacy and safety (e.g. immunogenicity).In the present work we show that by using ESI-TOF-MS analysis of entire EPO preparations after desialylation or after removal of N-linked oligosaccharides, exact mass determination of glycoprotein variants can be achieved, thus enabling its application in the lot-to-lot consistency control of the final product as well as during cell line and product development.Moreover, ESI-TOF-MS of subfractions of oligosaccharide mixtures obtained from enzymatically liberated glycans after IEX chromatography enabled detailed structural assignments of the total oligosaccharide mixtures derived from pharmaceutical glycoproteins. More... »

PAGES

861-865

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/978-90-481-3419-9_151

DOI

http://dx.doi.org/10.1007/978-90-481-3419-9_151

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1019463355


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